FDA Adverse Event
Malfunction
Summary report: N
T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY
MDR report key: 17613611
·
Received August 24, 2023
Report
- Report Number
- 3013756811-2023-120109
- Event Type
- Malfunction
- Date Received
- August 24, 2023
- Date of Event
- August 2, 2023
- Report Date
- August 24, 2023
- Manufacturer
- TANDEM DIABETES CARE
- Product Code
- QFG
- UDI-DI
- 00389152000107
- PMA / PMN Number
- K201214
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
NO PRODUCT WAS RETURNED FOR EVALUATION. SHOULD NEW RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. H3 OTHER TEXT : DEVICE NOT RETURNED.
Description of Event or Problem · 0
IT WAS REPORTED THAT AN UNEXPECTED RESET OCCURRED. CUSTOMER RELOADED THE CARTRIDGE AND SUCCESSFULLY RESUMED INSULIN DELIVERY. CUSTOMER¿S BLOOD GLUCOSE LEVEL WAS 143-145 MG/DL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2113922 | T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY | ALTERNATE CONTROLLER ENABLED INFUSION PUMP | QFG | TANDEM DIABETES CARE | 1000354 | 00389152000107 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female |